SANTA CRUZ, Calif.–(BUSINESS WIRE)–Versa Vascular appoints Bill Shields as CEO and announces $15 million in expanded Series C funding.
Author: Ken Dropiewski
Arch Biopartners to Expand Phase II Cardiac Surgery-Associated Acute Kidney Injury Trial to the United States
TORONTO, Aug. 11, 2026 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (TSX Venture: ARCH and OTCQB: ACHFF) today announced that the Company will expand its ongoing Phase II trial of LSALT peptide targeting cardiac surgery-associated acute kidney injury (“CS-AKI”) into the United States, following interest from clinicians at five leading U.S. institutions. The planned U.S. expansion builds on progress at the four Canadian clinical sites currently participating in the trial and patient data collected from the five sites in Turkey that were the first to recruit patients to the study. Patient recruitment has maintained momentum; there have been no adverse events related to the study drug, and AKI has occurred consistently among enrolled patients, validating trial design. These factors support the Company’s decision to expand the study with additional sites. Expanding the trial to the U.S. is intended to increase access to eligible patients and support continued recruitment. The Company is also continuing to grow the trial in Canada as one additional Canadian site moves through the activation process. “We are seeing strong interest from American clinicians to join our CS-AKI trial for LSALT peptide to protect patients from cardiac surgery-related acute kidney injury. Establishing a U.S. arm of the study will increase awareness of LSALT peptide and our Phase II trial among kidney care specialists, the pharmaceutical industry and potential partners,” said Richard Muruve, Chief Executive Officer of Arch Biopartners. The Company expects new U.S. clinical sites to require approximately four to six months to complete site preparation, contracting, regulatory review, training and other start-up activities before dosing their first patients. Timing will vary by institution and is subject to the completion of all applicable approvals. The Company will provide further updates as U.S. clinical sites complete the steps required to join and begin recruiting patients in the trial. About the CS-AKI Phase II Trial Cardiac surgery-associated acute kidney injury is a common complication following on-pump (heart-lung machine) cardiac surgery and can lead to longer hospital stays and worse outcomes. The trial is designed to evaluate whether LSALT peptide can reduce the rate of AKI in this setting. The CS-AKI Phase II trial is a multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Details of the Phase II trial can be viewed at ClinicalTrials.gov: NCT05879432. About Arch Biopartners Arch Biopartners Inc. is a therapeutic biotechnology company developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury. Arch’s development pipeline includes: LSALT peptide: in a Phase II trial targeting cardiac surgery-associated AKI.Cilastatin: a repurposed drug in a Phase II trial targeting toxin-induced AKI.CKD Platform: next-generation therapeutics targeting chronic kidney disease. These assets represent distinct, mechanism-based approaches focused on protecting the kidney from different causes of damage. Chronic kidney disease affects more than 800 million people worldwide,1 while acute kidney injury adds a further significant burden. Together, Arch’s programs target unmet needs across both acute and chronic kidney disease. Both Phase II programs are currently enrolling patients at Canadian clinical sites, with an additional Canadian site in development and a U.S. expansion of the CS-AKI trial underway. For more details about the Company’s science and ongoing clinical trials, please visit www.archbiopartners.com/our-science Follow Arch on LinkedIn, Bluesky, and X (formerly Twitter) for company updates and scientific content. The Company has 67,933,289 common shares outstanding. For more information, please contact: Aaron BensonDirector of CommunicationsArch Biopartners Inc.647-428-7031 Send a message or subscribe for updates at www.archbiopartners.com/contact-us Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of the Company’s future performance, liquidity, and capital resources, as well as the ongoing development of its drug candidates targeting chronic kidney disease and the dipeptidase-1 (DPEP1) pathway, including the outcomes of its clinical trials relating to LSALT peptide (Metablok) and cilastatin, the successful commercialization and marketing of its drug candidates, whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe, and other countries, its ability to raise capital to fund its business plans, the efficacy of its drug candidates compared to the drug candidates developed by competitors, its ability to retain and attract key management personnel, and the breadth of, and its ability to protect, its intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in the Company’s most recent annual audited financial statements and related management’s discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company undertakes no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including the Company’s most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR+”) website at www.sedarplus.ca. References: Mark, Patrick B., et al. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023. The Lancet, 2025;406(10518), 2461–2482. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01853-7/fulltext Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Heartbeat Health Named to the 2026 Inc. 5000 for the Second Consecutive Year, Ranking No. 299
Recognition places Heartbeat among the top 6% of America’s fastest-growing private companies NEW YORK, Aug. 11, 2026 /PRNewswire/ — Heartbeat Health, the nation’s largest virtual cardiology practice, today announced it has been ranked No. 299 on the 2026 Inc. 5000 list, earning placement…
CVRx Announces Sales Leadership Transition
Robert John to Depart as Chief Revenue Officer; Paul Verrastro Named Interim Head of SalesMINNEAPOLIS, Aug. 11, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that Robert John, Chief Revenue Officer, will depart the company, and that Paul Verrastro will assume the role of Interim Head of Sales, effective immediately. In his new role, Mr. Verrastro will lead CVRx’s sales organization while the company conducts a search for a permanent successor. Mr. Verrastro brings more than 30 years of medical device sales and marketing experience to the role. He has been with CVRx for over five years and recently moved into a new senior advisor role focused on commercial execution support. Prior to assuming this role, he was most recently Chief Marketing and Strategy Officer. Prior to joining CVRx, he held sales and marketing leadership positions at Guidant, Boston Scientific and Medtronic, much of that work focused on bringing novel therapies and technologies to market, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT). “Our revised commercial outlook and need to improve commercial execution have led us to make a change in sales leadership,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “I have full confidence in Paul’s ability to lead our sales team while we search for a new leader. He knows our business, our customers and our commercial strategy, and is well respected by the sales force. This continuity will serve us well as we work through this transition.” About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
Orchestra BioMed Reports Second Quarter 2026 Financial Results and Highlights Recent Business Updates
The BACKBEAT global pivotal trial (“BACKBEAT Trial”), conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by end of Q3 2026, with primary data presentation targeted for Q2 2027, assuming those endpoints are met.Virtue pivotal trial is advancing with further site activations and patient enrollments. $110 million cash balance provides projected runway into Q4 2027 and through key upcoming milestones, following $35 million in strategic capital from Medtronic and Ligand.Company to host R&D Day on November 12, 2026, in New York City, featuring in-depth reviews of both the AVIM Therapy and Virtue SAB programs. NEW HOPE, Pa., Aug. 10, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2026, and provided a business update on its two pivotal-stage cardiovascular programs: Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in pacemaker-indicated patients, being developed in strategic collaboration with Medtronic (NYSE: MDT), and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary in-stent restenosis. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, “The second quarter brought clarity on both the timeline and the scope of the AVIM Therapy opportunity that we are pursuing with Medtronic. We remain on track to reach or exceed our target of 284 evaluable randomized patients in the BACKBEAT Trial by the end of the third quarter of 2026 and maintain our objective to present primary endpoint data as a major conference late-breaker in the second quarter of 2027. The second FDA Breakthrough Device Designation for AVIM Therapy earned during the second quarter strengthens potential regulatory and reimbursement upside for this high-impact program.” Hochman continued, “Our conviction that Virtue SAB offers distinctive potential clinical advantages because of its differentiated approach to arterial drug delivery continues to grow as we advance site activations and patient enrollment for the Virtue pivotal trial. With a $110 million cash balance at quarter-end following $35 million received from Medtronic and Ligand during the quarter, both pivotal programs are funded through their next major milestones. We are excited to review each in detail at our R&D Day in November.” Q2 2026 and Recent Business Highlights: BACKBEAT Trial is on track to reach target of 284 evaluable randomized patients by end of Q3 2026. Assuming primary endpoints are met, Orchestra BioMed and Medtronic intend to submit primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by marketing application submissions to the FDA and global regulatory agencies.Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Including this most recent investment, Medtronic’s total capital contribution to Orchestra BioMed is nearly $82 million. Ligand has now provided $40 million in total capital to the Company.FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. Together, AVIM Therapy’s two BDDs now cover both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial.Advanced site activation and patient enrollment in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (“Virtue Trial”), a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis.Added to the Russell 3000® and Russell 2000® Indexes. Effective after the U.S. market close on June 26, 2026, Orchestra BioMed joined the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the 2026 Russell indexes reconstitution, broadening the Company’s visibility among institutional investors and index funds benchmarked to the Russell indexes. R&D Day: November 12, 2026The Company will host an R&D Day on November 12, 2026 in New York City. The event will feature presentations from management and leading physician investigators covering the AVIM Therapy and Virtue SAB programs, including recent program and pipeline developments. Additional details, including registration and webcast information, will be announced in the future. Financial Results for the Second Quarter Ended June 30, 2026 Cash and cash equivalents and Marketable securities totaled $110.0 million as of June 30, 2026.Net cash used in operating activities and for the purchase of fixed assets was $19.6 million during the second quarter of 2026, compared with $15.6 million for the second quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the second quarter of 2026.Research and development expenses for the second quarter of 2026 were $16.6 million, compared with $13.9 million for the second quarter in 2025, which represents an increase of 20%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for the second quarter of 2026 were $5.8 million, compared with $6.3 million for the second quarter of 2025, which represents a decrease of 7%. The decrease was primarily due to a decrease in stock-based compensation expense.Net loss attributable to common stockholders for the second quarter of 2026 was $24.1 million, or ($0.38) per share, compared with a net loss attributable to common stockholders of $19.4 million, or ($0.50) per share, for the second quarter of 2025, which represents an increase of 23%. Net loss attributable to common stockholders for the second quarter of 2026 included $2.7 million in interest expense for the second quarter of 2026 as compared to $0.5 million for the same period in 2025, of which a portion was non-cash in the current period. Non-cash stock-based compensation expense was $2.5 million as compared to $3.2 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and a global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) June 30, December 31, 2026 2025ASSETS CURRENT ASSETS: Cash and cash equivalents $20,472 $34,690 Marketable securities 89,491 71,822 Accounts receivable, net 51 95 Inventory 250 310 Prepaid expenses and other current assets 977 994 Total current assets 111,241 107,911 Property and equipment, net 2,045 1,715 Right-of-use assets 1,171 1,496 Strategic investments — 2,495 Deposits and other assets 1,243 1,240 TOTAL ASSETS $115,700 $114,857 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $6,132 $6,095 Accrued expenses and other liabilities 6,531 9,890 Operating lease liability, current portion 808 751 Total current liabilities 13,471 16,736 Royalty purchase agreement 34,593 16,482 Note payable 20,442 — Loan payable 14,397 14,268 Derivative liability 2,460 2,749 Operating lease liability, less current portion 520 936 Other long-term liabilities 397 308 TOTAL LIABILITIES 86,280 51,479 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at June 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000 10,097 9,808 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value, 10,000,000 shares authorized; — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 60,105,049 and 57,032,963 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively. 6 6 Additional paid-in capital 426,423 416,083 Accumulated other comprehensive (loss) income (81) 60 Accumulated deficit (407,025) (362,579)TOTAL STOCKHOLDERS’ EQUITY 19,323 53,570 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $115,700 $114,857 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended June 30, 2026 2025Revenue: Partnership revenue $ — 667 Product revenue 88 169 Total revenue 88 836 Expenses: Cost of product revenues 25 46 Research and development 16,590 13,853 Selling, general and administrative 5,829 6,264 Total expenses 22,444 20,163 Loss from operations (22,356) (19,327)Other (expense) income: Interest (expense) income, net (1,768) (36)Change in the fair value of derivative liability 324 — Gain on sale of strategic investments 45 — Total other (expense) income (1,399) (36)Net loss (23,755) (19,363)Adjustment to carrying value of Series A Preferred Stock (324) — Net loss attributable to common stockholders $(24,079) (19,363) Net loss attributable to common stockholders per share Basic and diluted $(0.38) (0.50)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 63,812,098 38,392,716 Comprehensive loss Net loss $(23,755) (19,363)Unrealized loss on marketable securities (41) (21)Comprehensive loss $(23,796) (19,384)
BridgeBio Reports Second Quarter 2026 Financial Results and Corporate Updates
– $243.7 million in total second quarter revenues, primarily comprised of $222.4 million of U.S. Attruby® net product revenue, with growth led by the treatment-naïve segment as physicians increasingly start and keep patients on Attruby – Attruby is the first ATTR-CM therapy associated with direct kidney protection, with post-hoc analyses published in Circulation: Heart Failure showing a profile consistent with ACE inhibitors, ARBs, and SGLT2s including an early, reversible eGFR dip, an improved chronic eGFR slope relative to placebo, and a 13.7% reduction in urinary albumin-to-creatinine ratio through Month 30; the magnitude of the acute eGFR dip was positively associated with greater early cardiovascular benefit; BridgeBio will explore the potential for Attruby to treat other orphan kidney indications – Real-world evidence continues to differentiate Attruby from tafamidis, with an independent propensity score-matched analysis of 286 patient pairs from the TriNetX network published in JSCAI associating acoramidis with a 37% reduction in composite cardiovascular events (p=0.002) and a 34% reduction in hospitalizations (p=0.002) at six months; further independent RWE using electronic health records are expected, and we are confident Attruby will consistently demonstrate clinical superiority over tafamidis to the benefit of patients and healthcare delivery systems for which heart failure remains a top concern – All three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026); encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either; oral infigratinib for achondroplasia has been submitted, with U.S. launch expected mid-2027 – Diagnosis and awareness continue to accelerate ahead of the launches: in ADH, more than 2,200 unique patients are now identified under the dedicated ICD-10 code, at approximately 70 new diagnoses per month; in LGMD2I/R9, BridgeBio is investing in awareness and multidisciplinary care at MDA Care Center Network sites, where we expect 85% of target physicians to be familiar with the BBP-418 profile and data by launch – The oral encaleret and oral infigratinib franchises continue to expand beyond their first indications: RECLAIM-HP in chronic hypoparathyroidism has begun screening patients with topline data anticipated in late 2027 or early 2028, CALIBRATE-PEDS in pediatric ADH1 has completed enrollment in its first cohort, and a Phase 2 update in hypochondroplasia is expected in the second half of 2026 – $720.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which does not include the $1 billion preferred equity financing that closed on July 1, 2026 – BridgeBio will host a Commercial Day in New York City on October 8, 2026, to discuss commercial readiness and launch strategy across its three upcoming launches PALO ALTO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the second quarter ended June 30, 2026, and provided an update on Attruby’s commercial progress. Pipeline Overview: ProgramStatusNext expected milestoneAcoramidis for ATTR-CMApproved in U.S., E.U., Japan, Switzerland, Brazil, and U.K.New data to be shared at ESC 2026BBP-418 for LGMD2I/R9PDUFA date set for November 27, 2026 with Priority ReviewLaunch upon FDA approvalEncaleret for ADH1PDUFA date set for May 8, 2027 with Priority Review; MAA submitted to EMALaunch upon FDA approvalOral infigratinib for achondroplasiaNDA submitted to FDAFDA sets PDUFA dateOral Encaleret for chronic hypoparathyroidismFirst investigational sites activated for RECLAIM-HP, Phase 3 studyFirst participant dosed in Q3 2026Oral infigratinib for hypochondroplasiaACCEL 2/3 enrollment ongoingPhase 2 clinical trial update in 2H 2026Depleter for ATTR-CMDevelopment candidate nominationSubmit IND to the FDA in 2027 “I’m excited by the growing body of evidence continuing to demonstrate Attruby is the drug of choice for all ATTR-CM patients, and particularly for those who are treatment-naïve, including the first-ever demonstration of early, sustained kidney-protective effects in ATTR-CM alongside the cardiac benefit we’ve established. Furthermore, this was the quarter all three of our pipeline programs, BBP-418, encaleret, and infigratinib, moved from data into active regulatory review, with our first PDUFA date now set for November 27, 2026, which is a level of strategic execution and discipline I’m proud of. Finally, with the $1 billion preferred equity financing we completed, we have a balance sheet sized to run all three launches at full strength, without diverting resources from the development engine that produced them,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio. Commercial Updates:The second quarter total revenues, net totaled $243.7 million, comprised of $222.4 million of U.S. Attruby net product revenue, $15.4 million from royalty revenue, and $5.8 million in license and services revenue. “We continue to see strong growth this quarter for Attruby with our first-line share climbing again,” said Matt Outten, Chief Commercial Officer of BridgeBio. “What comes next will continue to shape BridgeBio’s next chapter as we prepare for three potential approvals in three different diseases, all with best-in-class potential, each backed by the same commercial engine that made Attruby a success. We look forward to continuing to deliver for patients and addressing the gaps within the treatment paradigm for rare disease.” Pipeline Updates:Attruby (acoramidis) – First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): New post-hoc analyses published in Circulation: Heart Failure showed acoramidis was associated with a rapid, reversible estimated glomerular filtration rate (eGFR) dip alongside a placebo-corrected 15.5% reduction in urinary albumin-to-creatinine ratio (UACR) by Day 28, followed by a sustained improvement in chronic eGFR slope (+2.47 mL/min/1.73m²/year) and a 13.7% UACR reduction through Month 30. This profile resembles that of direct-acting kidney medicines such as ACE inhibitors, ARBs, and SGLT2 inhibitors, and has not previously been observed with any approved ATTR-CM therapy. Participants with larger eGFR dips had a 58% lower risk of death or cardiovascular hospitalization in year one, suggesting the kidney effect may contribute to acoramidis’ early cardiovascular benefit.New data from ATTRibute-CM presented in two late-breaking oral presentations at Heart Failure 2026 further demonstrated acoramidis’ differentiated clinical profile. The first showed a reduction in the risk of outpatient worsening heart failure by 41% versus placebo with separation of curves seen within 30 days and sustained through Month 30. The second showed a significant reduction in serum transthyretin variability, which is associated with lower mortality.Real-world evidence continues to demonstrate that Attruby is differentiated from other therapies in the speed and strength of benefit. An independent propensity score-matched analysis of 286 patient pairs from the TriNetX network, presented at SCAI 2026 Scientific Sessions and published in JSCAI, associated acoramidis with a 37% reduction in composite cardiovascular events (HR 0.63; p=0.002) and a 34% reduction in hospitalizations (HR 0.67; p=0.002) at six months, with effects deepening at nine months and significant reductions across heart failure exacerbation, arrhythmia, and acute kidney injury. A separate propensity score-weighted analysis observed a 43% reduction in outpatient diuretic intensification (HR 0.57; p=0.021) versus tafamidis. A third independent study conducted in EPIC COSMOS and to be published later in 2026 validated the comparative effectiveness of acoramidis over tafamidis. These three real-world datasets converge on consistent, statistically significant benefit in contemporary patients on modern background therapy, reinforcing that Attruby’s stabilization advantage is showing up in outcomes that matter to physicians, patients, and payers.BridgeBio initiated ASCEND-ATTR, a Phase 4 study using cardiac MRI and echocardiography to characterize the long-term effects of acoramidis on disease reversal as measured by cardiac structure, function, and amyloid burden over 36 months. This builds on the evidence of regression observed in ATTRibute-CM and the open-label extension.Additional data will be shared in two oral presentations and six moderated posters at the European Society of Cardiology (ESC) Congress 2026. BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9): BridgeBio believes BBP-418 is positioned to become the first approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD.On May 27, 2026, the FDA accepted the Company’s New Drug Application (NDA) for BBP-418 and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. No advisory committee meeting is currently planned.FORTIFY, the Phase 3 clinical trial of BBP-418, successfully met all pre-specified primary and secondary endpoints of its 12-month interim analysis, supporting its potential as a disease-modifying therapy. The topline results can be found here.Additional positive results demonstrating the rapid and consistent treatment effect and favorable safety profile of BBP-418 were presented in March at the 2026 MDA Clinical and Scientific Conference in a late-breaking oral presentation.1At the 19th International Congress on Neuromuscular Diseases in July 2026, BridgeBio presented interim FORTIFY data showing favorable patient-reported outcomes for BBP-418-treated individuals compared to placebo, demonstrating that the improvements observed on functional outcomes and biomarkers translate to how patients feel and function.BridgeBio invested $100,000 to strengthen multidisciplinary LGMD care through a Muscular Dystrophy Association (MDA) Care Advance Grant supporting initiatives at Stanford Health Care and the University of Minnesota and engaged the LGMD2I/R9 community at the 2026 European LGMD2I/R9 Conference and the 2026 Iowa Wellstone Dystroglycanopathy Patient & Family Conference.BridgeBio’s neuromuscular U.S. field teams are hired, trained, and deployed across medical, commercial, and market access, engaging in scientific exchange, disease state education, and account profiling as appropriate in the pre-approval setting. Promotional activity will commence only upon FDA approval, consistent with regulatory requirements.Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe.The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age in the first half of 2027, and in LGMD2M/R13 and LGMD2U/R20 in the near future. Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism: BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1, in both the U.S. and the EU.The FDA re-considered its review designation of the Company’s NDA filing for encaleret in ADH1 and has granted Priority Review, with a PDUFA target action date of May 8, 2027. No advisory committee meeting is currently planned.BridgeBio submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1.Diagnosis of ADH1 in the U.S. continues to accelerate, with more than 2,200 unique patients identified under the dedicated ICD-10 code for ADH (E20.810) from its introduction in October 2023 through June 2026, a rate of approximately 70 new diagnoses per month.CALIBRATE-PEDS, the registrational Phase 2/3 study of encaleret in pediatric ADH1, completed enrollment in the first of four cohorts (adolescents 12 to 17 years of age).RECLAIM-HP, the Phase 3 study of encaleret in chronic hypoparathyroidism, has activated its first investigational sites and screening has initiated. Chronic hypoparathyroidism affects approximately 200,000 patients in the U.S. and EU, and represents a substantial expansion of the encaleret opportunity beyond ADH1. Oral infigratinib – FGFR3 inhibitor for achondroplasia and hypochondroplasia: BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia.The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026. BridgeBio anticipates a U.S. launch in mid-2027 and an EU approval in the second half of 2027.Oral infigratinib has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations from the FDA, and Orphan Drug designation from both the FDA and the EMA.Results from PROPEL 3, the Phase 3 trial of oral infigratinib in achondroplasia, were published in the New England Journal of Medicine2 and simultaneously presented at the International Congress of Children’s Bone Health 2026. Oral infigratinib is the only achondroplasia program with Phase 3 results published in the New England Journal of Medicine. In these results3, oral infigratinib significantly improved arm span Z-score versus placebo (LS mean +0.37 SD; p
Feinstein Institutes Finds Mitochondria Transplantation Dramatically Enhances Heart Recovery After Cardiac Arrest
MANHASSET, N.Y.–(BUSINESS WIRE)–With only approximately 10 percent of out-of-hospital cardiac arrest patients surviving, and many facing severe neurological or organ damage, a new study from Northwell Health’s Feinstein Institutes for Medical Research offers hope, revealing that mitochondria transplantation dramatically improves heart recovery and protects organs. Published as a letter to the editor in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), this pivotal large
AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial, Results to Be Presented at Major Heart Failure Conference This Fall
NEWTON, Mass. and SHEFAYIM, Israel, Aug. 10, 2026 /PRNewswire/ — AQUAPASS, developer of a noninvasive, kidney-independent therapy for fluid overload management in patients experiencing heart failure and chronic or end-stage kidney disease, announced completion of enrollment in its FDA…
Autonomix Medical Congratulates Co-Founder & Chief Medical Officer Dr. Robert Schwartz on Receiving Prestigious 2026 Cardiovascular Tech Forum Lifetime Achievement Award
Recognition honors one of the medical technology industry’s most influential innovators, whose career has helped shape modern cardiovascular care THE WOODLANDS, TX, Aug. 10, 2026 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today congratulated its Chief Medical Officer, Robert Schwartz, M.S., M.D., FACC, on being named the recipient of the 2026 Cardiovascular Tech Forum (CTF) Lifetime Achievement Award, recognizing his extraordinary career and lasting contributions to cardiovascular medicine, innovation and medical technology. Dr. Schwartz will be honored during Octane’s 2026 Cardiovascular Tech Forum on September 18, 2026, in Newport Beach, California. The annual award recognizes individuals whose pioneering work has transformed the cardiovascular technology landscape through scientific achievement, clinical innovation and entrepreneurial leadership. Throughout his distinguished career, Dr. Schwartz has authored more than 500 scientific publications, holds more than 200 patents and has founded multiple medical technology companies whose innovations have changed how the field operates, including the Watchman device, which he co-invented and which was later acquired by Boston Scientific. “Rob’s career has been defined by a relentless pursuit of innovation that has improved the lives of countless patients around the world,” said Brad Hauser, President and Chief Executive Officer of Autonomix. “Few physician innovators have had the breadth of impact that Rob has achieved across cardiovascular medicine and medical technology. From pioneering breakthrough therapies to mentoring entrepreneurs and advancing next-generation medical devices, his vision continues to shape the future of healthcare. We are honored to have him as our Co-Founder and Chief Medical Officer, where his experience and leadership are helping drive Autonomix’s mission to redefine how diseases involving the peripheral nervous system are diagnosed and treated.” Hauser continued, “This well-deserved recognition not only celebrates Rob’s extraordinary legacy but also underscores the caliber of scientific and clinical leadership guiding Autonomix as we continue advancing our first-in-class technology platform.” “I am honored to receive this recognition from the Cardiovascular Tech Forum,” said Dr. Schwartz. “Innovation in medical technology has always been driven by collaboration among physicians, engineers and entrepreneurs committed to improving patient outcomes. I’m grateful to have had the opportunity to contribute to this field throughout my career and look forward to continuing that work through organizations like Autonomix.” The Cardiovascular Tech Forum brings together leading physicians, engineers, entrepreneurs and investors focused on advancing cardiovascular innovation. For more information on CTF 2026, visit their website. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential effectiveness and clinical benefits of Autonomix’s nerve-targeted treatments for pancreatic cancer pain and other conditions, the versatility and scalability of the Company’s platform technology, the potential for future clinical applications across multiple organ systems, the strength and scope of the Company’s intellectual property portfolio, and the potential for the Company’s patented technologies to support patient selection, procedural guidance and post-treatment monitoring across multiple neuromodulation applications. Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 27, 2026, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLC Jenene Thomas 908.824.0775 autonomix@jtcir.com
Nanox.AI Optimizes Medical Imaging AI Application Framework for Intel Core Ultra Processors with OpenVINO
On-premise medical imaging AI framework uses Intel Core Ultra processors and Intel’s OpenVINO toolkit to accelerate edge inference within healthcare environments PETACH TIKVA, Israel – August 10 – Nanox AI Ltd., a subsidiary of Nano-X Imaging Ltd. (NASDAQ: NNOX), today announced the optimization of its medical imaging AI application framework for Intel CoreUltra processors using Intel’s OpenVINO toolkit. The framework is designed to support AI applications running on an on-premise edge device within healthcare facilities, enabling organizations to evaluate and deploy CT imaging AI applications while keeping imaging data within their own infrastructure. Nanox.AI solutions analyze routine medical CT scans to help identify patients with findings correlated with chronic conditions in areas including cardiac, liver and bone health. By leveraging existing CT imaging workflows, Nanox.AI aims to help healthcare organizations derive additional clinical value from scans that have already been performed and support preventive care management. The optimized AI application framework ran inference successfully and efficiently on Intel Core Ultra-class hardware using OpenVINO, demonstrating its suitability for on-premise AI processing in medical imaging environments. Intel Core Ultra processors provide a heterogeneous AI architecture with CPU, GPU and NPU compute resources, while OpenVINO helps developers optimize and deploy AI workloads across Intel hardware. For healthcare organizations, this combination can support local inference at the edge, help reduce dependence on cloud connectivity, and enable deployment models aligned with hospital infrastructure requirements. “Nanox.AI is focused on helping healthcare organizations deploy advanced medical imaging AI applications efficiently within their existing infrastructure,” said Sharon Saban, General Manager of Nanox.AI. “Our work with Intel demonstrates how optimized edge inference can help bring AI-enabled imaging insights closer to the point of care.” “Healthcare organizations need practical ways to bring AI closer to clinical workflows while supporting performance, responsiveness and local data control,” said Alex Flores, General Manager, Health and Life Science, Edge Computing GroupGoup, Intel. “Nanox.AI’s optimization work with Intel Core Ultra processors and Intel’s OpenVINO toolkit shows how edge AI can help medical imaging applications run efficiently on-premise, giving providers a scalable path to evaluate and deploy AI-enabled insights within their existing infrastructure.” Nanox.AI’s technology has also been featured in Intel’s partner resources as an example of a solution built with Intel technology in Intel’s published partner brief. For more information about Nanox.AI and its suite of solutions, visit www.nanox.vision/ai. ©Intel, the Intel logo and other Intel marks are trademarks of Intel Corporation or its subsidiaries. 1 See intel.com/processor claims: Intel® Core™ Ultra Processors (Series 3). Performance varies by use, configuration, and other factors. Results may vary. Intel does not control or audit third-party data. You should consult other sources to evaluate accuracy. About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, statements regarding: the Company’s expected commercialization efforts, business strategy and long-term growth opportunities; the expected timing, pace, extent and success of deployments, installations, activations and utilization of Nanox.ARC systems, including under the Nanox Imaging Network; the anticipated benefits, timing and extent of activity under existing commercial, distribution and strategic agreements, including contemplated deployments of hundreds of systems over the coming years; the potential outcome, scope and timing of the evaluation of strategic alternatives relating to the Company’s South Korea operations, including an expanded restructuring, a potential sale, wind-down or closure of all or part of such operations; the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; and (xii) risks related to litigation which may result in significant liability and damage to the Company’s reputation. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
